| Assay (alkalimetric, calculated on anhydrous substance) |
99.5 - 100.5 % |
| Identity (IR-spectrum) |
passes test |
| Appearance |
white to almost white, fine powder |
| Appearance of solution (200 g/l; water) |
clear (≤ 3 NTU) and not more intense in color than reference solution Y₇, BY₇ or GY₇ |
| Sulphate (SO₄) |
≤ 50 ppm |
| Heavy metals (as Pb) |
≤ 5 ppm |
| Al (Aluminium) |
≤ 0.2 ppm |
| As (Arsenic) |
≤ 1 ppm |
| Hg (Mercury) |
≤ 1 ppm |
| Pb (Lead) |
≤ 0.5 ppm |
| Oxalates (as C₂H₂O₄) |
≤ 100 ppm |
| Residual solvents (ICH (Q3C)) |
excluded by manufacturing process |
| Readily carbonisable substance |
passes test |
| Sulfated ash (600 °C) |
≤ 0.05 % |
| Water (according to Karl Fischer) |
≤ 0.5 % |
| Bacterial endotoxins |
< 0.5 |
| Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*). |
|
| Corresponds to Ph. Eur., BP, JP, USP, E 330, FCC Conforms to the purity criteria on food additives according to the current European Commission Regulation. |
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